Last updated: 02/29/2024 18:40:45
Ancillary study on a sub-population of the chronic hepatitis B patients enrolled in the TH HBV VV-001 study to investigate the potential shedding of ChAd155-hIi-HBV after intramuscular administration
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the TH HBV VV-001 study
Trial description: This study will be performed as an ancillary study on a sub-population of the TH HBV VV-001 study including patients who will receive the highest dose of ChAd155-hIi-HBV with no co-administration. The purpose of this study is to assess the potential shedding of ChAd155-hIi-HBV after intramuscular administration.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of subjects with Chimpanzee Adenovirus (ChAd)155 vector Deoxyribonucleic Acid (DNA) in throat swab above the limit of detection (LOD) of the quantitative polymerase chain reaction (qPCR) assay
Timeframe: At Day 1, 3, 8, 15, 31
Number of subjects with ChAd155 vector DNA in urine above the LOD of the qPCR assay
Timeframe: At Day 1, 3, 8, 15, 31
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: ChAd155-hIi-HBV high dose formulation
Biological/vaccine: HBc-HBs/AS01B-4 high dose formulation
Biological/vaccine: Placebo
Enrollment:
76
Observational study model:
Not applicable
Primary completion date:
2022-02-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
GSK3528869A
Collaborators
Not applicable
Study date(s)
October 2020 to March 2022
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
No
- Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the patient prior to performance of any study specific procedure.
- Patients met any exclusion criterion of the TH HBV VV-001 study (GSK study ID 204852).
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the patient prior to performance of any study specific procedure.
- Patients who met all inclusion criteria and were randomised to the Step B of the TH HBV VV-001 study (GSK study ID 204852).
Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Exclusion criteria:
Patients met any exclusion criterion of the TH HBV VV-001 study (GSK study ID 204852).
Trial location(s)
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Study Complete
Location
GSK Investigational Site
London, London, United Kingdom, E1 1BB
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Study documents
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2022-02-03
Actual study completion date
2022-02-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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